Yupelri
NDC Package 65302-043-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Yupelri is revefenacin is a long-term medication used to treat an ongoing lung disease, chronic obstructive pulmonary disease (COPD). Marketed by The Ritedose Corporation, this product is identified by NDC 65302-043 and is authorized under FDA application NDA210598.

Identification & Billing

NDC Package Code
65302-043-07
Package Description
7 POUCH in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
Product Code
65302-043
11-Digit Billing Format
65302004307

Clinical Specifications

Proprietary Name
Yupelri
Dosage Form
-
Usage Information
Revefenacin is a long-term medication used to treat an ongoing lung disease, chronic obstructive pulmonary disease (COPD). It must be used regularly to reduce and prevent symptoms such as shortness of breath, cough, and wheezing. This medication belongs to a class of drugs known as anticholinergics. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Revefenacin does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.

Regulatory & Marketing

Labeler Name
The Ritedose Corporation
FDA Application #
NDA210598
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-03-2018
End Marketing Date
07-31-2019
Listing Expiration
07-31-2019
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65302-043). Click a package code to view its specific billing and regulatory data.

65302-043-30
30 POUCH in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65302-043-07 identifies a specific commercial package of 7 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 3 ml in 1 vial, single-dose of Yupelri, labeled by The Ritedose Corporation. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by The Ritedose Corporation on December 03, 2018. The current certification is valid through July 31, 2019.

What are the primary indications for this medication?

Revefenacin is a long-term medication used to treat an ongoing lung disease, chronic obstructive pulmonary disease (COPD). It must be used regularly to reduce and prevent symptoms such as shortness of breath, cough, and wheezing. This medication belongs to a class of drugs known as anticholinergics. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Revefenacin does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.

How is this The Ritedose Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65302004307. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65302-043-07
11-Digit CMS (5-4-2)
65302-0043-07

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.